Functional Expertise
We deliver proven consultants across every key function in the life sciences lifecycle—from early research and clinical trials through regulatory approvals, commercialization, and post-market compliance. Whether you’re filling gaps in capacity, capability, or leadership, our network of expert talent is ready to support your goals.
Research & Clinical Development
Clinical Strategy & Operations
Due Diligence
SOP Development & Program Management
Clinical Systems (eTMF, CDMS)
Biostatistics, Programming, & Data Management
Regulatory Affairs & Market Access
Regulatory Strategy, Operations, & Communications
Regulatory CMC & Labeling
Medical Writing, eCTD Publishing
Health Authority Interactions
Advertising & Promotional Review
Market Access & Reimbursement Strategy
Global Submissions & Commercial Product Compliance
Drug Safety & Pharmacovigilance
AE Review & Signal Detection
REMS & Benefit/Risk Management
Safety Surveillance & Compliance
PV Auditing & Post-Marketing Safety
Risk Mitigation & REMS Program Management
Quality & Compliance
GxP Audits (Site, Process, Corporate)
Inspection Readiness & Mock Audits
Trial Master File Review
Quality Systems & SOP Development
Continuous Quality Improvement
Supplier Qualification & Post-Approval Quality Oversight
Medical Affairs
Medical Strategy & Scientific Review
Phase 3b/4 Planning & Execution
KOL Engagement & Advisory Boards
Medical Education & Communication
HEOR Support
Post-Marketing Data Analysis & Publications
Commercialization & Lifecycle Management
Launch Strategy & Execution
Lifecycle Management & Product Extensions
RWE Studies & Outcomes Research
Post-Marketing Surveillance
Legacy Product Support